ATOGEPANT - Generic Drug Details

What are the generic sources for atogepant and what is the scope of freedom to operate?

Atogepant is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Atogepant has one hundred and thirty-nine patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for ATOGEPANT

International Patents:	139
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	23
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ATOGEPANT
What excipients (inactive ingredients) are in ATOGEPANT?	ATOGEPANT excipients list
DailyMed Link:	ATOGEPANT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ATOGEPANT

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ATOGEPANT

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Iowa	PHASE4
Patient-Centered Outcomes Research Institute	PHASE4
AbbVie	PHASE4

See all ATOGEPANT clinical trials

Pharmacology for ATOGEPANT

Drug Class	Calcitonin Gene-related Peptide Receptor Antagonist
Mechanism of Action	Calcitonin Gene-related Peptide Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ATOGEPANT

N02CD	Calcitonin gene-related peptide (CGRP) antagonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for ATOGEPANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-002	Sep 28, 2021		RX	Yes	No			Y	Y
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-002	Sep 28, 2021		RX	Yes	No
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-003	Sep 28, 2021		RX	Yes	Yes
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-002	Sep 28, 2021		RX	Yes	No			Y	Y
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-003	Sep 28, 2021		RX	Yes	Yes			Y	Y
Abbvie	QULIPTA	atogepant	TABLET;ORAL	215206-001	Sep 28, 2021		RX	Yes	No

EU/EMA Drug Approvals for ATOGEPANT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH & Co. KG	Aquipta	atogepant	EMEA/H/C/005871Aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month	Authorised	no	no	no	2023-08-11

International Patents for ATOGEPANT

Country	Patent Number	Title	Estimated Expiration
Denmark	2821407
Canada	2937315
European Patent Office	2849568	PROCÉDÉ DE FABRICATION D'ANTAGONISTES DE RÉCEPTEURS DU CGRP (PROCESS FOR MAKING CGRP RECEPTOR ANTAGONISTS)
Slovenia	2638042
Hong Kong	1200163	哌啶羧基酰胺阿酰啶 降鈣素基因相關肽 受體拮抗劑 (PIPERIDINONE CARBOXAMIDE AZAINDANE CGRP RECEPTOR ANTAGONISTS (AZAINDANE)(CGRP))
Taiwan	201520213	Piperidinone carboxamide azaindane CGRP receptor antagonists

Supplementary Protection Certificates for ATOGEPANT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2638042	2390026-9	Sweden		PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814
2638042	PA2023532,C2638042	Lithuania		PRODUCT NAME: ATOGEPANTAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1750 20230811
2638042	CR 2023 00033	Denmark		PRODUCT NAME: ATOGEPANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/23/1750 20230814
2638042	2023C/541	Belgium		PRODUCT NAME: ATOGEPANT OF EEN FARMACEUTISCH AANVAARDAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1750 20230814
2638042	C02638042/01	Switzerland		PRODUCT NAME: ATOGEPANT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69128 06.03.2024
2638042	34/2023	Austria		PRODUCT NAME: ATOGEPANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1750 (MITTEILUNG) 20230814

Market Dynamics and Financial Trajectory for Atogepant

Last updated: July 27, 2025

Introduction

Atogepant stands at the forefront of migraine preventive therapies, representing a significant advancement within the burgeoning calcitonin gene-related peptide (CGRP) antagonists segment. Since its FDA approval in September 2021, atogepant has garnered considerable attention for its clinical efficacy, safety profile, and its potential to reshape migraine management. This analysis examines the evolving market landscape, competitive forces, regulatory influences, and financial trajectories shaping atogepant’s prospects.

Market Landscape of Migraine Therapeutics

Epidemiology and Unmet Needs

Migraine affects over 1 billion individuals globally, accounting for substantial morbidity and societal economic burden. The U.S. migraine population alone exceeds 40 million adults, with many patients experiencing frequent attacks resistant to existing therapies.[1] Traditionally, options included NSAIDs, triptans, and prophylactics such as beta-blockers, antiepileptics, and antidepressants, often limited by adverse effects or contraindications.

Rise of CGRP Antagonists

The approval of CGRP monoclonal antibodies (mAbs) — including erenumab, fremanezumab, and galcanezumab — marked the beginning of targeted preventive therapy for migraine. These biologics, administered via monthly or quarterly injections, demonstrated improved efficacy and tolerability, yet their high cost and injectable nature constrained widespread adoption.[2]

Small-molecule CGRP receptor antagonists (gepants), such as atogepant, oral formulations introduced an alternative, offering daily oral dosing and potentially broader accessibility. The market for gepants is projected to reach $1.8 billion by 2027 globally, driven by increasing awareness and demand for effective, on-demand, and preventive migraine options.[3]

Product Profile: Atogepant

Mechanism of Action and Clinical Profile

Atogepant functions as a selective, oral CGRP receptor antagonist. It effectively reduces migraine frequency in episodic and chronic migraine sufferers, demonstrated by pivotal Phase III trials.[4] Its safety profile, characterized by low hepatic toxicity and minimal cardiovascular risk, makes it suitable for long-term use, aligning with patient preferences for oral over injectable therapies.

Regulatory Status and Market Approvals

Beyond FDA approval, atogepant's regulatory journey in other jurisdictions remains under review. The drug’s approval has spurred investment from pharmaceutical companies and health systems, encouraging broader commercialization strategies.

Market Dynamics

Competitive Landscape

The landscape features several key players:

• Erenumab (Aimovig): First CGRP mAb approved (2018), with extensive market penetration.
• Fremanezumab (Ajovy): Efficacious, dosing flexibility.
• Galcanezumab (Emgality): Also approved for episodic and chronic migraine.
• Ubrogepant (Ubrelvy): Oral acute migraine treatment, competitor in the gepant class for acute therapy.
• Rimegepant (Nurtec ODT): Acute and preventive migraine treatment.

Atogepant’s primary differentiators include oral preemptive therapy for episodic migraine and its safety profile, potentially capturing a market segment hesitant to use injectables or biologics.

Pricing and Reimbursement

Pricing strategies will significantly impact atogepant’s market penetration. Initially priced comparable to other oral preventive therapies (~$600–$800 per month), payor coverage and formulary inclusion are crucial. As with other CGRP agents, reimbursement strategies are expected to evolve with real-world evidence demonstrating cost-effectiveness through reduced migraine-related disability and healthcare utilization.

Patient and Physician Adoption

Physician prescribing habits, patient acceptance, and administration convenience will influence atogepant's adoption curve. Educational campaigns highlighting its safety, efficacy, and oral administration will be pivotal in expanding use, especially among patients dissatisfied with current options.

Financial Trajectory

Sales Forecasting and Revenue Potential

Projected sales of atogepant hinge on several factors, including market size, competitive dynamics, pricing strategies, and regulatory developments. Assuming a moderate uptake, initial global revenues could reach hundreds of millions within the first two years post-launch, scaling to over $1 billion by 2027 with increased market penetration and expanded indications.[5]

Investment and R&D Costs

Revenue growth depends on continued investments in clinical development, post-marketing studies, and marketing. Initial R&D expenditures for atogepant are estimated in the hundreds of millions, with ongoing costs associated with clinical trials and regulatory filings.

Long-term Financial Outlook

As the migraine therapeutics market matures, atogepant’s financial trajectory may benefit from:

• Expanding indications (e.g., chronic migraine, preventive therapy in diverse populations).
• Consolidation through partnerships or acquisitions.
• Cost reductions via manufacturing scale-up.
• Potential biosimilar or generic emergence, although less relevant for small molecules compared to biologics.

Regulatory and Market Challenges

Key risks include:

• Regulatory delays or restrictions.
• Competitive pressures from emerging gepants or biologics.
• Reimbursement hurdles, especially in cost-sensitive markets.
• Clinical safety concerns or adverse effects emerging post-market.

Emerging Trends and Future Outlook

Innovations such as personalized medicine approaches, pharmacogenomics, and combination therapies could influence atogepant’s market share. Additionally, development of next-generation gepants with improved pharmacokinetics or dual-action mechanisms may threaten current formulations.

The integration of digital health tools for migraine tracking and patient adherence could further enhance atogepant's market penetration, aligning with broader industry trends towards patient-centric care.

Key Takeaways

• Market Positioning: Atogepant benefits from its oral administration, targeting patients seeking an alternative to injectables; its safety profile enhances its appeal.
• Growth Drivers: Increasing migraine prevalence, unmet needs, and healthcare cost savings through preventive therapy underpin growth potential.
• Competitive Strategy: Pricing, reimbursement negotiations, and clinician education will be decisive for market uptake.
• Financial Outlook: Revenue forecasts suggest a trajectory toward $1 billion annually by 2027, with significant upside potential as indications expand.
• Market Risks: Competition, regulatory hurdles, and payer policies remain key considerations.

---

FAQs

Q1: What differentiates atogepant from other CGRP antagonists?
A1: Its oral, daily dosing regimen and favorable safety profile distinguish atogepant from injectable monoclonal antibodies, offering a convenient option for preventive migraine management.

Q2: What is the current regulatory status of atogepant?
A2: The FDA approved atogepant in September 2021 for episodic migraine prevention. Other jurisdictions are reviewing the submission, with approval timelines varying.

Q3: How does atogepant's pricing compare to its competitors?
A3: Initial pricing aligns with other oral migraine preventives, roughly $600–$800/month. Reimbursement negotiations and real-world evidence will influence final patient access costs.

Q4: What are the primary challenges facing atogepant’s market penetration?
A4: Challenges include competitive pressure from biologics and other gepants, payor reimbursement policies, and physician adoption rates.

Q5: What is the long-term outlook for atogepant in migraine treatment?
A5: Its market potential remains substantial, especially if expanded indications are approved, and it continues to be incorporated into personalized, multi-modal migraine care strategies.

---

References

1. Global Burden of Disease Study 2019.
2. Goadsby PJ, et al. "CGRP Antagonists and Migraine Prevention," Neurology, 2020.
3. Grand View Research. "Migraine Drugs Market Size & Share." 2022.
4. Lipton RB, et al. "Efficacy and Safety of Atogepant for Migraine Prevention," NEJM, 2021.
5. Evaluate Pharma. "Migraine Market Forecast," 2022.